Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology
ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
BACKGROUND: When FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.
RECOMMENDATION: Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.
Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms such as:
．Sudden shortness of breath or difficulty breathing
．Chest pain or pain in your back
．Coughing up blood
．Excessive sweating
．Clammy or bluish colored skin
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
美國FDA首次核准使用tofacitinib（Xeljanz, Xeljanz XR）時，要求進行類風濕性關節炎（rheumatoid arthritis, RA）病人之臨床試驗，以評估兩種劑量（10 mg一天兩次或是5 mg一天兩次）併用methotrexate與使用腫瘤壞死因子（tumor necrosis factor, TNF）抑制劑的藥物相比，其對於心臟相關事件、癌症和伺機性感染之風險。納入試驗中的RA病人需至少50歲且至少有一個心血管相關危險因子。
在最近的試驗分析中，安全監測委員會發現，與每天兩次使用tofacitinib 5 mg或使用TNF抑制劑治療的病人相比，每天兩次使用tofacitinib 10 mg治療的病人其肺部血栓和死亡的發生率增加。因此美國FDA發布藥物安全警訊，RA病人使用tofacitinib 10 mg一天兩次可能會增加肺部血栓和死亡之風險。美國FDA針對RA病人尚未核准此藥使用10 mg一天兩次的劑量，該劑量目前美國FDA僅核准用於潰瘍性結腸炎之病人。
醫療專業人員在治療病人的特殊病症時，仍應遵循tofacitinib之處方資訊中的建議。監測病人肺栓塞的臨床表徵和症狀，並建議病人若發生此症狀時，應立即就醫。
病人不應在未事先與醫療專業人員確認的情況下停止或改變tofacitinib劑量，以免病情惡化。服用tofacitinib的病人如果出現肺部血栓症狀或其他異常症狀，應立即就醫，例如：
．突然呼吸短促或呼吸困難
．胸部疼痛或背部疼痛
．咳血
．過度出汗
．皮膚發青
[Posted 02/25/2019]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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